NIH: Few Stem Cell Colonies Likely Available for Research ... Of Approved Lines, Many Are Failing
By Justin Gillis and Rick Weiss
Washington Post Staff Writers

Wednesday, March 3, 2004; Page A03

At least 16 of the 78 human stem cell colonies approved by President Bush for federal research money have died or
failed to reproduce in their laboratory dishes -- making them useless to scientists -- and most of the others are
unlikely ever to become available for disease research, according to interviews and a new analysis by the National
Institutes of Health.

The unpublished NIH analysis, circulating yesterday on Capitol Hill, said only about one-quarter of the Bush-approved
cell colonies are ever likely to be available, far fewer than supporters of the president's policy had predicted.

Moreover, several of the Bush-approved colonies available to researchers are beginning to show genetic abnormalities,
potentially undermining their medical usefulness, researchers said.

Advocates of stem cell research, who believe it offers possibilities for curing a range of diseases from diabetes to
Parkinson's, said these developments confirmed fears they expressed in 2001, when Bush announced that he would allow
federal funding only for stem cell colonies that had been extracted from human embryos as of Aug. 9 of that year.

Two Democrats, Reps. Henry A. Waxman (Calif.) and Louise M. Slaughter (N.Y.), yesterday accused the administration of
misleading the public by continuing to contend that the policy allows for robust scientific research. In a stinging
letter to the White House, they declared that the new NIH analysis "casts into doubt the adequacy of your policy on
stem cell research."

A bipartisan group of House members -- including some Republicans who until now accepted the Bush policy -- are
gathering signatures on a letter of their own calling for a policy change.

Sensing that the tide may be shifting in their favor, scientific organizations have stepped up their campaign to ease
restrictions on the controversial research, which uses embryos slated for destruction by fertility clinics.

"I think the administration has been trying to implement the existing policy in good faith," said Lawrence Soler of the
Juvenile Diabetes Research Foundation, which supports expanding federally funded research. "I think it's just come to a
point now of having to face that we're not as far as we had hoped we'd be -- or even, we believe, where the
administration had hoped we'd be."

The administration said it was planning no change of policy.

"The president remains committed to exploring the promise of stem cell research but continues to firmly believe that we
should not cross a fundamental moral line by funding or encouraging the destruction of human embryos," said White House
spokesman Trent Duffy.

The debate centers on a policy that has been among the most contentious of Bush's tenure. Democrats have generally been
united in supporting broad research on embryonic stem cells, while the Republican majority in Congress has been sharply
divided.

Scientists are excited about the cells because, unlike most adult cells, they can morph into nearly any tissue in the
human body. Researchers hope to grow large numbers of cells in the laboratory and then coax them into becoming brain
cells that might cure Parkinson's disease, pancreatic cells to cure diabetes, and so on.

But creating a laboratory colony of stem cells requires destroying a five-day-old human embryo. Social conservatives
have opposed the work, saying embryo destruction is tantamount to murder. Torn between this group and disease-research
advocates, including former first lady Nancy Reagan, Bush announced a compromise on Aug. 9, 2001, that precluded
federally funded research on cells from embryos destroyed after that date. That effectively froze the supply at its
then-current level.

The president initially said more than 60 colonies would qualify -- a number that surprised many biologists, who had
not been aware of colonies created at private companies and foreign laboratories. The large number helped to quell
criticism that Bush was limiting a promising field of medicine. As others announced that they, too, had cells from
before that date, the number of eligible colonies grew to 78.

But in recent weeks, the NIH has been posting information on the Internet showing that 16 of the colonies "failed to
expand into undifferentiated cell cultures." That is biology-speak for saying the cells are useless for further
research, though it is not clear how many colonies are dead and how many have simply stopped reproducing.

At one company, CyThera Inc. of San Diego, nine colonies have collapsed, eliminating more than 10 percent of the
administration's list. So have six colonies at a laboratory in Sweden and one at a company in Athens, Ga.

It is not unusual for cell colonies to "crash" in biology, particularly in early research, when scientists do not
really know how best to grow the cells. Usually, they would simply replace a dead cell colony -- but under Bush's
policy, they cannot.

Most of the remaining Bush-approved colonies are in overseas labs. The NIH acknowledged recently that most of those
labs have shown no interest in supplying stem cells to U.S. researchers. Some foreign labs also face legal restrictions
on exportation.

Add all the factors together and the "best-case scenario" is that only 23 cell colonies will ever be available to U.S.
researchers, an NIH administrator, James Battey, said recently in the unpublished report to Congress.

In addition, several of the 15 approved cell colonies that are being distributed to scientists have been going bad --
developing severe genetic abnormalities that could make them useless as therapies and, in some cases, impractical even
for research. Experts suspect that other cells in use are also accumulating DNA glitches that will require them to be
replaced at some point.

Many scientists said the Bush-approved cell colonies were sufficient to get a start on the research. But as they learn
more about how to nurture stem cells and use them to create new tissues, some of them now say the restrictions are
becoming increasingly burdensome.

Some are using private money to create fresh colonies, but those funds are limited. Leading stem cell researchers said
the United States is falling behind as foreign labs, unencumbered by Bush's restrictions, grow new colonies using
improved techniques.

"Federally funded scientists have to drive Model T's, while Korean scientists get to drive around in the newest
Porsche," said George Daley, a stem cell researcher at Harvard University. "It's crazy."

SOURCE: Washington Post, DC
http://www.washingtonpost.com/wp-dyn/articles/A24621-2004Mar2.html

Reference:

NIH Human Embryonic Stem Cell Registry
http://stemcells.nih.gov/registry/

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